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AMAG Gets FDA Nod, ABMD Hits All-time High, GLMD's NAFLD Trial Flops, NKTR Abuzz

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Today's Daily Dose brings you news about expanded FDA approval for AMAG's Makena and Abiomed's Impella; Bristol Myers' investment in Nektar; Galmed's disappointment over ARRIVE trial, and Vertex Pharma's encouraging results of NaV1.8 Inhibitor VX-150 in a mid-stage trial.

Read on...

The FDA has approved AMAG Pharmaceuticals Inc.'s (AMAG) subcutaneous auto-injector form of Makena, designed as a ready-to-administer treatment to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered one preterm baby in the past.

Makena, a long acting form of natural progesterone, in intramuscular injection formulation was approved by the FDA in February 2011.

AMAG developed the Makena auto-injector with its device partner Antares Pharma Inc. (ATRS).

Makena's market share has increased over the years. Sales of Makena were $251 million in 2015, $334 million in 2016, and it is expected to be $385 million to $395 million in 2017. The Company is slated to report fourth quarter and full year 2017 financial results on February 28, 2018.

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AMAG closed Wednesday's trading at $13.90, up 1.46%. In after-hours, the stock was up 19.78% to $16.65. ATRS closed Wednesday's trading at $1.98, down 1.49%. In after-hours, the stock was up 19.70% to $2.37.

Abiomed Inc. (ABMD) has received an expanded FDA approval for its Impella 2.5 and Impella CP heart pumps during elective and urgent high risk percutaneous coronary intervention procedures.

The expanded indication confirms Impella support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction, noted the Company.

Last September, the Company's Impella RP heart pump secured the regulatory blessing, becoming the only percutaneous temporary ventricular support device that is FDA-approved as safe and effective for right heart failure.

ABMD touched an all-time high of $256.13 in intraday trading on Wednesday, before closing at $255.47, up 9.18%.

Bristol-Myers Squibb Co. (BMY) is making an upfront cash payment of $1.0 billion and an equity investment of $850 million in Nektar Therapeutics (NKTR) as part of a global strategic development and commercialization collaboration for Nektar's lead immuno-oncology program, NKTR-214.

The collaboration aims to evaluate the full-potential of NKTR-214 plus Bristol Myers' Opdivo across numerous tumors.

The deal entitles Bristol-Myers Squibb to obtain exclusive rights for NKTR-214 in 20 indications across 9 tumors included in the joint clinical development plan for a specified time period. Nektar is also eligible to receive an additional $1.78 billion in milestones, of which $1.43 billion are development and regulatory milestones and the remainder are sales milestones.

If approved, the global profits on NKTR-214 will be shared by the companies, with Nektar receiving 65% and Bristol-Myers Squibb 35%.

Last November, Nektar reported early encouraging data from PIVOT-02, a phase 1/2 study of its drug candidate NKTR-214 in combination with Opdivo in patients with locally advanced or metastatic melanoma (mM), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), urothelial carcinoma, or triple-negative breast cancer (TNBC). The Phase 1/2 PIVOT clinical study is ongoing in over 350 patients.

NKTR closed Wednesday's trading at $84.00, up 11.02%.

Shares of Galmed Pharmaceuticals Ltd. (GLMD) plunged 42% on Wednesday, following the failure of its proof-of-concept phase IIa clinical trial of Aramchol in patients with HIV-associated Non-alcoholic fatty liver disease (NAFLD) and lipodystrophy.

The trial, dubbed ARRIVE, did not meet the primary endpoint of improvement of liver fat at 12 weeks, as measured by MRI-PDFF.

A phase IIb clinical trial evaluating Aramchol in patients with biopsy proven NASH who are overweight or obese, and who are pre-diabetic or type-II-diabetic, dubbed ARREST, is underway. Top line data from ARREST is expected in Q2 2018.

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GLMD closed Wednesday's trading at $5.45, down 42.39%.

The FDA has accepted for review Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) New Drug Application for JEMDEL lotion, a topical steroid, proposed for the treatment for plaque psoriasis.

The regulatory agency's decision on JEMDEL is expected on October 5, 2018.

If approved, JEMDEL will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks, noted the Company.

VRX closed Wednesday's trading at $18.37, up 2.34%. In after-hours, the stock was up 1.36% to $18.62.

Vertex Pharmaceuticals Inc.'s (VRTX) investigational drug VX-150, a NaV1.8 inhibitor, has demonstrated statistically significant relief of acute pain in patients following bunionectomy surgery in a phase II study.

This phase 2 study is the second positive proof-of-concept study for VX-150 and provides further validation for the use of a NaV1.8 inhibitor for the treatment of pain. Last January, the Company announced data from a phase II cross-over study of VX-150 in people with pain from osteoarthritis of the knee, which showed statistically significant pain relief.

A third phase II study of VX-150 is currently ongoing in neuropathic pain, with data expected in early 2019.

VRTX closed Wednesday's trading at $157.26, up 2.02%.

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